Long-term safety and efficacy of antimuscarinic add-on therapy in patients with overactive bladder who had a suboptimal response to mirabegron monotherapy: A multicenter, randomized study in Japan (MILAI II study).

Objectives: To evaluate the long-term safety (primary objective) and efficacy (secondary objective) of antimuscarinic add-on therapy in patients receiving mirabegron.

Methods: During a 2-week screening period, patients (aged ≥20 years, mirabegron treatment for ≥6 weeks, residual overactive bladder symptoms) received mirabegron 50 mg once daily. These patients were subsequently randomized to 52 weeks' treatment with mirabegron 50 mg/day plus an antimuscarinic (solifenacin 5 mg, propiverine 20 mg, imidafenacin 0.

Therapeutic effect of propiverine hydrochloride on mixed-type urinary incontinence in women: The Female Urgency and Stress Urinary Incontinence Study of Propiverine Hydrochloride trial.

Objectives: To show the efficacy of propiverine hydrochloride in the management of symptoms of stress urinary incontinence in female patients with mixed-type urinary incontinence.

Methods: The study was carried out as a multicenter single-arm clinical trial at 64 institutions in Japan. The participants were female patients aged ≥20 years with mixed-type urinary incontinence.

Safety and efficacy of the combination of once-daily tadalafil and alpha-1 blocker in Japanese men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: A randomized, placebo-controlled, cross-over study.

Objectives: To evaluate the safety and efficacy of tadalafil plus α -blocker combination therapy in Japanese patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

Methods: The present multicenter, randomized, double-blind, placebo-controlled, two-period cross-over study compared the effects of tadalafil and a placebo added to ongoing α -blocker therapy. A total of 171 Japanese patients were randomized.

Nocturnal Polyuria and Hypertension in Patients with Lifestyle Related Diseases and Overactive Bladder.

Purpose: The objective of this multicenter cross-sectional study was to investigate the relationship of nocturnal polyuria in patients with common lifestyle related diseases and overactive bladder, with special attention to hypertension.

Materials And Methods: After baseline assessment, patients recorded 24-hour urinary frequency/volume, blood pressure and heart rate for 3 days. They were stratified into 4 groups based on mean blood pressure, including no hypertension, and controllable, untreated and uncontrolled hypertension, respectively.

Clinical Guideline for Female Lower Urinary Tract Symptoms.

The "Japanese Clinical Guideline for Female Lower Urinary Tract Symptoms," published in Japan in November 2013, contains two algorithms (a primary and a specialized treatment algorithm) that are novel worldwide as they cover female lower urinary tract symptoms other than urinary incontinence. For primary treatment, necessary types of evaluation include querying the patient regarding symptoms and medical history, examining physical findings, and performing urinalysis. The types of evaluations that should be performed for select cases include evaluation with symptom/quality of life (QOL) questionnaires, urination records, residual urine measurement, urine cytology, urine culture, serum creatinine measurement, and ultrasonography.

Efficacy and Safety of the Selective β3 -Adrenoceptor Agonist Mirabegron in Japanese Patients with Overactive Bladder: A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study.

Objectives: To evaluate the efficacy and safety of the β3 -adrenoceptor agonist, mirabegron, compared with placebo in Japanese patients with overactive bladder (OAB).

Methods: Patients with OAB symptoms for ≥24 weeks, ≥8 micturitions/24 h on average, and ≥1 episode of urgency and/or urgency incontinence/24 h were randomized to mirabegron (25, 50 or 100 mg) or placebo for 12 weeks. The primary endpoint was change from baseline to end of study in the mean number of micturitions/24 h.

Pathways Involving Beta-3 Adrenergic Receptors Modulate Cold Stress-Induced Detrusor Overactivity in Conscious Rats.

Objective: To investigate pathways involving beta-3 adrenergic receptors (ARs) in detrusor overactivity induced by cold stress, we determined if the beta-3 AR agonist CL316243 could modulate the cold stress-induced detrusor overactivity in normal rats.

Methods: Two days prior to cystometric investigations, the bladders of 10-week-old female Sprague-Dawley rats were cannulated. Cystometric measurements of the unanesthetized, unrestricted rats were taken to estimate baseline values at room temperature (RT, 27 ± 2 °C) for 20 min.

[UNDIFFERENTIATED CARCINOMA OF THE URETER WITH FETAL CLINICAL COURSE: A CASE REPORT].

Undifferentiated carcinoma of ureter is rare neoplastic lesion, and the natural history of undifferentiated carcinoma of ureter has not been known well yet. We hereby presented an autopsy case of undifferentiated carcinoma of the ureter with rapid progression from the initial stage. A 62-year-old male visited the local urologist complaining of asymptomatic gross hematuria.

Expression of 5-Hydroxytryptamine Receptors in Human Urinary Bladders with Benign Prostatic Hyperplasia.

Introduction: This study investigated the mRNA expression pattern and distribution of 5-hydroxytryptamine (5-HT) receptors 5-HT2A, 5-HT2B, 5-HT3A, 5-HT4, and 5-HT7 within the urothelium and detrusor of normal bladder tissue and in the urothelium of bladders from patients with benign prostatic hyperplasia (BPH).

Methods: Normal urinary bladder specimens were obtained from 13 patients undergoing radical cystectomy due to bladder cancer (normal group) and BPH specimens were obtained from 27 benign prostatic obstruction patients receiving transurethral prostatectomy or retropubic prostatectomy. Receptor subtype mRNA expression was determined by real-time reverse transcription polymerase chain reaction on urothelium, detrusor, and whole mucosal preparations.

Tadalafil 5 mg once daily for the treatment of Asian men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: analyses of data pooled from three randomized, double-blind, placebo-controlled studies.

Objectives: Assess the efficacy and safety of tadalafil 5 mg once-daily in Asian men with lower urinary tract symptoms by pooling data from three clinical studies.

Methods: Data on 1199 Japanese, Korean, and Taiwanese men given tadalafil 5 mg (n = 601) or placebo (n = 598) were pooled from three double-blind, placebo-controlled, 12-week studies. Efficacy measures included International Prostate Symptom Score, and Patient and Clinician Global Impressions of Improvement.

Engineered bone marrow-derived cell sheets restore structure and function of radiation-injured rat urinary bladders.

Previously, we reported that implantation of isolated single bone marrow-derived cells into radiation-injured urinary bladders could restore structure and function. However, injections of isolated single cells had some limitations. Thus, in this study, we produced bone marrow-derived cell sheets in temperature-responsive culture dishes that release the monolayer sheets intact.

Safety and efficacy of mirabegron as 'add-on' therapy in patients with overactive bladder treated with solifenacin: a post-marketing, open-label study in Japan (MILAI study).

Objective: To examine the safety and efficacy of mirabegron as 'add-on' therapy to solifenacin in patients with overactive bladder (OAB).

Patients And Methods: This multicentre, open-label, phase IV study enrolled patients aged ≥20 years with OAB, as determined by an OAB symptom score (OABSS) total of ≥3 points and an OABSS Question 3 score of ≥2 points, who were being treated with solifenacin at a stable dose of 2.5 or 5 mg once daily for at least 4 weeks.

[A case of advanced prostate fibrosarcoma that reacted well to chemotherapy].

Prostate fibrosarcoma is an extremely rare tumor for which complete excision has been the mainstay of treatment. Although chemotherapy has been attempted in cases with positive surgical margins and/or advanced stage disease, the effectiveness of this therapy has not been established. Herein, we report a case of advanced prostate fibrosarcoma that reacted well to chemotherapy.

Impact of dynamic transrectal ultrasonography on pelvic organ prolapse.

Purpose: We developed a new method to evaluate pelvic organ prolapse dynamically in patients in supine and standing positions using transrectal ultrasonography. We visualized the descent and prolapse of pelvic organs in real time using dynamic transrectal ultrasonography. The dynamic transrectal ultrasonography findings were compared with intraoperative findings.

Muscarinic receptors mediate cold stress-induced detrusor overactivity in type 2 diabetes mellitus rats.

Objectives: This study determined if muscarinic receptors could mediate the cold stress-induced detrusor overactivity induced in type 2 diabetes mellitus rats.

Methods: Ten-week-old female Goto-Kakizaki diabetic rats (n = 12) and Wister Kyoto non-diabetic rats (n = 12) were maintained on a high-fat diet for 4 weeks. Cystometric investigations of the unanesthetized rats were carried out at room temperature (27 ± 2°C) for 20 min.

[Comparison of ventral and dorsal lymph node metastases of obturator nerve in radical prostatectomy].

Objective: In this study, we assessed the significance of complete dissection of the dorsal lymph node of the obturator nerve during radical prostatectomy.

Patients And Methods: Fifty-six patients undergoing open radical prostatectomy and pelvic lymph node dissection for treatment of prostate cancer were included in this study. Neoadjuvant hormonal therapy and radiation therapy were not performed in any of the patients.

Implantation of autologous adipose-derived cells reconstructs functional urethral sphincters in rabbit cryoinjured urethra.

We investigated the ability of autologous adipose-derived cells injected into cryoinjured rabbit urethras to improve urinary continence and explored the possible mechanisms by which it occurred. Adipose tissue was harvested from the perivesical region of nine 10-week-old female New Zealand White rabbits and cultured for 7 days. Immediately after harvesting the tissue, we injured the internal urethral orifice by spraying liquid nitrogen for 20 s.

Phase III, randomised, double-blind, placebo-controlled study of the β3-adrenoceptor agonist mirabegron, 50 mg once daily, in Japanese patients with overactive bladder.

Objective: To evaluate the efficacy and safety of the β3-adrenoceptor agonist mirabegron, in a Japanese population with overactive bladder (OAB).

Patients And Methods: This randomised, double-blind, placebo-controlled phase III study enrolled adult patients experiencing OAB symptoms for ≥24 weeks. Patients with ≥ 8 micturitions/24 h and ≥1 urgency episode/24 h or ≥1 urgency incontinence episode/24 h were randomised to once-daily placebo, mirabegron 50 mg or tolterodine 4 mg (as an active comparator, without testing for non-inferiority of efficacy and safety) for 12 weeks.

Alpha1 -adrenergic receptors mediate bladder overactivity induced by cold stress in rats with bladder outlet obstruction.

Purpose: To determine if alpha1 -adrenergic receptors (AR) mediate bladder overactivity induced by cold stress in rats with bladder outlet obstruction (BOO).

Materials And Methods: The urethras of 10-week-old female Sprague-Dawley rats were ligated to create BOO. After 4 weeks, cystometric investigations were performed at room temperature (RT, 27 ± 2°C) for 20 min.

Overexpression of O-GlcNAc by prostate cancer cells is significantly associated with poor prognosis of patients.

Background: O-linked β-N-acetylglucosamine (O-GlcNAc) is a glycan essential for fundamental cellular processes such as transcription/translation, nuclear transport, protein stability and protein-protein interactions. However, the role of O-GlcNAc in prostate cancer progression of patients remains poorly unknown. Here we investigated the clinicopathological significance of O-GlcNAc expression level in prostate cancer.

Multicenter, randomized, sham-controlled study on the efficacy of magnetic stimulation for women with urgency urinary incontinence.

Objectives: To evaluate the efficacy and safety of magnetic stimulation for the treatment of urinary incontinence in women with overactive bladder.

Methods: A total of 151 women with urgency incontinence were randomized to the active stimulation group or the sham stimulation group in a 2:1 order. An armchair type magnetic stimulator was used for 25-min magnetic stimulation twice a week, with the maximum magnetic flux density of 560 mT peak at 10 Hz.

Efficacy and safety of advanced renal cell carcinoma patients treated with sorafenib: roles of cytokine pretreatment.

Background: We conducted a retrospective, questionnaire-based analysis to assess the outcomes of advanced renal cell carcinoma (RCC) in Japanese patients treated with sorafenib in the daily clinical setting.

Patients And Methods: Patients (n = 110) were treated with sorafenib 400 mg twice daily at 12 centers. Overall survival (OS), progression-free survival (PFS), safety, and prognostic factors associated with PFS were assessed.